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Development of an Optimal Antibiotic Regime for Long-term Therapy in Stable Chronic Obstructive Pulmonary Disease (COPD)

This study is currently recruiting participants.
Verified May 2012 by University College, London
Sponsor:
Collaborators:
Royal Free Hampstead NHS Trust
University of Cambridge
National Institute for Health Research, United Kingdom
Information provided by:
University College, London
ClinicalTrials.gov Identifier:
NCT01398072
First received: July 18, 2011
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

Chronic Obstructive Pulmonary Disease (COPD) is the cause of considerable deaths, and exacerbations (flare up of symptoms) are a major cause of hospital admission in the UK. Bacterial infections play an important role in the development of COPD, however, there is little information available about the use of long term antibiotics in the treatment of this disease. Therefore the purpose of this study is to identify the best antibiotic regime for treating patients with COPD who have persistent bacterial infection in their lung. We will test a variety of approaches including both older and newer regimes prescribed either on a daily basis at a lower dose or in "pulsed" courses (for example, every other day or five days every month). The three antibiotics tested in this study are: moxifloxacin, azithromycin and doxycycline. This is a 13 weeks study conducted at the Royal Free Hospital, London. It is expected that approximately 200 patients will be selected for this study. The information we get from this study may help us to treat future patients with COPD better.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD).
 Drug: Moxifloxacin
Drug: Azithromycin
Drug: Doxycycline
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: A Phase III Single-blind, Randomised Placebo Controlled Trial of Long Term Therapy in Patients With Stable COPD Using Moxifloxacin, Azithromycin and Doxycycline: a Bayesian Decision Analysis, Including Other Criteria, Will be Used to Distinguish the Optimal Antibiotic Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University College, London:

Primary Outcome Measures:
  • To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo [ Time Frame: Week 14 post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure changes in lung function measure, health status and exacerbations. [ Time Frame: week 14 post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Moxifloxacin Drug: Moxifloxacin
An oral dose of 400 mg once daily for 5 consecutive days every 4 weeks.
Active Comparator: Azithromycin Drug: Azithromycin
An oral dose of 250 mg once daily three times a week (every other day).
Active Comparator: Doxycycline Drug: Doxycycline
An oral dose of 100 mg once daily.
Placebo Comparator: Placebo Drug: Placebo
Oral dose of one table once daily.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed COPD diagnosis
  • Informed Consent: Patients must give their signed and dated written informed consent to participate
  • Gender: Male or female patients
  • Age: ≥ 45 years of age at screening
  • Produce sputum regularly (produce sputum in at least 3 months of a year)
  • Able to complete questionnaires for health status and symptoms and considered able to comply with the dosing regimen.
  • Severity of disease: Patients with a measured FEV1<80% of predicted normal values as determined at screening. An average of three spirometry readings will be taken.

Exclusion Criteria:

  • Patients with TB, other chronic respiratory disease (e.g. chronic asthma, bronchiectasis, pulmonary fibrosis), patients with hepatic or renal impairment and patients with prolonged QT interval and other cardiac abnormalities.
  • Patients with known hypersensitivity to the antibiotics under evaluation.
  • Patients on long term antibiotics for other conditions.
  • Patients with uncontrolled hypertension.
  • Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding.
  • Patients with a history of long QT syndrome or whose QTc measured at Visit 1 is prolonged (>450 msec for males and females) as confirmed by the ECG assessor.
  • Clinically relevant abnormal laboratory values at the screening assessment that could interfere with the objectives of the trial or safety of the volunteer.
  • Patient taking clinically significant contraindicated medication, as per the SmPCs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398072

Contacts
Contact: Ethaar El-Emir, PhD 0044 2073177510 ethaar.el-emir@nhs.net

Locations
United Kingdom
Academic Unit of Respiratory Medicine, Royal Free Hospital Recruiting
London, United Kingdom, NW3 2PF
Contact: Ethaar El-Emir, PhD     0044 2073177510     ethaar.el-emir@nhs.net    
Principal Investigator: Jadwiga A Wedzicha, MA, MD, FRCP            
Sponsors and Collaborators
University College, London
Royal Free Hampstead NHS Trust
University of Cambridge
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Jadwiga A Wedzicha University College, London
  More Information

No publications provided

Responsible Party: Alison Evans, University College London
ClinicalTrials.gov Identifier: NCT01398072     History of Changes
Other Study ID Numbers: 11/0078
Study First Received: July 18, 2011
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Anti-Bacterial Agents
Doxycycline
Doxycycline hyclate
Azithromycin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013